Kornimate/medical-research-clean huggingface dataset:
peptide vaccination with pd-l1 and pd-l2 peptides in untreated chronic lymphatic leukemia.

Conditions: Chronic Lymphocytic Leukemia

Summary: this study is investigating the efficacy of pd-l1 and pd-l2 peptides in untreated cll patients with unmutated ighv gene status.

chronic lymphocytic leukemia (cll) is an incurable disease with the unmutated immunoglobulin heavy chain variable region (ighv) gene status being an unfavorable prognostic marker. these patients have shorter time to first treatment which consist of toxic chemotherapy. programmed death ligand 1 (pd-l1) and programmed death ligand 2 (pd-l2) are immune checkpoints hampering immune responses in many tumors including cll. these proteins are expressed by suppressive bystander cells as well as cll cells. vaccinating subcutaneously with pd-l1 and pd-l2 peptides mobilises cytoxic t-cells specific towards pd-l1 and pd-l2 expressing cells. in this study we investigate if the pd-l1 and pd-l2 specific responses can overcome leukemic cells in cll.

Eligibility criteria:
inclusion criteria: * cll according to national guidelines (lymphoma.dk). * unmutated ighv gene according to eric recommendations.(25) * no prior cll directed treatment * age ≥ 18 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * no life-threatening conditions * adequate bone marrow function: neutrophils \> 1,0 x 109/l; platelets \> 100 x 109/l * adequate renal function: glomeruli filtration rate (egfr)/1,73 m2 \> 50 ml/min * adequate liver function: aspartate aminotransferase \< 100 u/l * for fertile women: agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment. * for men: agreement to use contraceptive measures and agreement to refrain from donating sperm. exclusion criteria: * other active malignant diseases requiring treatment. * significant medical condition per investigators judgement e.g. severe asthma or chronic obstructive lung disease (cold), poorly regulated heart condition, insulin dependent diabetes mellitus. * acute or chronic viral/bacterial infection e.g. human immunodeficiency virus (hiv), cytomegalo virus (cmv), epstein-barr virus (ebv), hepatitis or tuberculosis * serious known allergies or earlier anaphylactic reactions. * known sensibility towards montanide isa51 * any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. * pregnant and breastfeeding women. * fertile women not using secure contraception with a failure rate less than \< 1% * psychiatric disorders that according to the investigator could influence compliance. * treatment with other experimental drugs
prediction of neurological outcome of children after a traumatic brain injury based on an integrated predictive model

Conditions: Traumatic Brain Injury

Summary: this study aims to develop a integrated predictive model based on serum biomarkers, hrv, and an innovative computerized classifier output, to predict the patient long term neurological outcome after a moderate or severe tbi in children.

traumatic brain injury (tbi) is a major cause of morbidity and mortality in children. most children with moderate and severe tbi have long term sequelae including neurological deficit, cognitive impairment and behavioural disorders. in the acute care setting, neither clinicians nor researchers are able to adequately predict the long term outcome of children with tbi, consequently limiting their ability to tailor medical care, rehabilitation and support services. improving our understanding of a tbi patient's exact cerebral status and prognosis is a critical step toward optimized and personalized patient management. in this research study, an innovative and integrated model will be developed to improve the prognostication in the early phase of a tbi. this model will combine key clinical variables commonly collected in the acute care setting and combine these with cutting-edge empirical measures: 1) biomarkers; 2) a new physiological monitoring based on heart-rate variability (hrv) to assess the integrity of the autonomic system; and 3) a computerized classification tool developed using the concept of artificial intelligence to continuously categorize the patient's cerebral status.

Eligibility criteria:
inclusion criteria: children 1) \<18 years; 2) admitted to the paediatric intensive care unit at the centre hospitalier universitaire ste-justine; 3) moderate (glasgow coma scale (gcs): 9-12) or severe tbi (gcs ≤8), assessed after initial resuscitation; 4) admitted to the paediatric intensive care unit less than 24 hours after the initial tbi and 5) written parental consent. patients with either inflicted or accidental tbi will be included as they characterize different but important population, our model should be valuable for both. exclusion criteria: children 1) suspected of being brain death at the time of paediatric intensive care unit entry (gcs 3 and loss of all brain stem reflexes); 2) with a pacemaker (hrv monitoring unreliable); and/or 3) patients or parents who do not speak or read english or french.

Keywords: outcome paediatric critical care
functional and metabolic effects of ketone bodies on human atrial tissue in patients with and without heart failure

Conditions: Heart Failure; Ischemia Reperfusion Injury; Mitochondrial Pathology

Summary: this proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.

ketone bodies are high energy molecules which are naturally occurring in the body during fasting or stress. recently, ketone bodies have been shown to improve cardiac function in patients with heart failure(1) through a mechanism, which has yet to be elaborated. we wish to evaluate the effects of ketone body administration on cardiac tissue subjected to ischemia reperfusion injury. we will evaluate contractile force of the and the mitochondrial performance. cardiac atrial tissue will be obtained from patients undergoing coronary artery bypass grafting (cabg) or valve replacement surgery. patients will be recruited after signing an informed consent and allocated in heart failure / non-heart failure groups based on a clinical evaluation.

Eligibility criteria:
inclusion criteria: * ef \ 45%, hospitalized for elective cabg or heart valve surgery exclusion criteria: * myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.
salivary free cortisol response to cosyntropin stimulation test in mitotane treated patients

Conditions: Adrenal Insufficiency; Adrenal Cancer

Summary: in mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases cortisol binding globulin levels (cbg), artificially raising total cortisol. salivary free cortisol (sc) is not affected by cbg alterations, and reflects the free serum cortisol. in the current study, investigators will assess serum and sc responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other etiology. investigators will compare results between groups and try to demonstrate the superiority of sc in assessing adrenal function in mitotane treated patients.

80-90% of circulating cortisol is bound to cortisol binding globulin (cbg) or transcortin, whereas only 3-10% is in the free state. salivary free cortisol (sc) is an index of plasma free cortisol. in previous studies it was shown that in low-dose cosyntropin stimulation test, sc increases significantly in normal but not in hypoadrenal patients. it was suggested that dynamic assessment of the sc response to acth may be particularly helpful whenever the measurement of serum cortisol is complicated by increased or decreased cbg levels. adrenocortical carcinoma (acc) is a rare malignancy with a heterogeneous presentation and a variable but generally poor prognosis. mitotane is the main drug for acc treatment and it plays a role both in adjuvant treatment after complete resection and in recurrent, inoperable and/or metastatic acc. mitotane blocks adrenocortical steroid synthesis and also exerts a specific cytotoxic effect on adrenocortical cells. mitotane induces adrenal insufficiency, requiring hydrocortisone replacement therapy. in mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases cbg levels, artificially raising total cortisol. sc is not affected by cbg alterations, and reflects the free serum cortisol and may be more accurate in diagnosing hypoadrenalism in mitotane treated patients. in the current study, investigators will assess serum and sc responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from any other etiology. investigators will compare results between groups and try to demonstrate the superiority of sc in assessing adrenal function in mitotane treated patients.

Eligibility criteria:
inclusion criteria: * mitotane treated * known hypoadrenlism exclusion criteria: * pregnancy

Keywords: cosyntropin salivary free cortisol mitotane
a study to compare the effectiveness and safety of fesoterodine and placebo in an elderly population of patients who go to the toilet very frequently due to overactive bladder.

Conditions: Urinary Bladder, Overactive

Summary: the drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. it is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.


Eligibility criteria:
inclusion criteria: * male or female ≥65 years old. * overactive bladder symptoms for at least 3 months prior to study start. * eight or more micturitions per 24 hours as confirmed by diary records exclusion criteria: * predominant stress urinary incontinence * active or recurrent bladder infections * other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.

Keywords: overactive bladder syndrome fesoterodine elderly flexible dose regimen urgency frequency urge urinary incontinence anticholinergic antimuscarinic
ideal dosage for sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia

Conditions: Arthritis Knee; Arthritis Hip

Summary: this study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective knee or hip arthroplasty under spinal anesthesia * bmi\>25 * american society of anesthesiologists (asa) classification i, ii, iii exclusion criteria: * patient refusal * contraindication for spinal anesthesia * contraindication for remimazolam infusion * history of hypersensitivity to remimazolam * history of chronic use of benzodiazepine or opioid * baseline moaa/s score of 4 or lower * pregnancy
irbesartan-hydrochlorothiazide phase iv study: treatment of hypertension in chinese population

Conditions: Hypertension

Summary: to analyse the control rate of irbesartan/hydrochlorothiazide(hctz) (coaprovel) in the treatment of patients with mild to moderate primary hypertension.


Eligibility criteria:
inclusion criteria: * systolic blood pressure \< 180 mmhg * 90 mmhg ≤ diastolic blood pressure \< 110 mmhg exclusion criteria: * pregnancy or lactation. women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method * known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.) * presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or sick sinus syndrome * alat\[sgpt\]\>2 times of upper limit， * asat\[sgot\]\>2 times of upper limit * patients with known renal disease * serum potassium \> normal upper limit * uncontroled bd（fbg\>10mmol/l or pbg\>12.22mmol/l) * patients treated with tricyclic antidepressants * clinical hematological disease. * patients with a history of irbesartan, or hydrochlorothiazide sensitivity defined as irbesartan, or hydrochlorothiazide discontinuation due to medically significant adverse effects. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
trial for femoroacetabular impingement treatment

Conditions: Femoroacetabular Impingement

Summary: femoroacetabular impingement (fai) describes a condition of the hip where additional bone results in the abutment of the femoral neck against the rim of the acetabulum. this gives rise to localised cartilage damage and pain, but also increases the risk of developing osteoarthritis. the purpose of this study is to compare the effectiveness of arthroscopic surgery versus physiotherapy and activity modification for the treatment of this condition.


Eligibility criteria:
inclusion criteria: * symptomatic patients * age 18-60 years * clinical and radiological evidence of fai * competent to consent exclusion criteria: * prior hip surgery * established osteoarthritis (kellgren-lawrence \>/= 2) * hip dysplasia (centre-edge angle \< 20 degrees on radiograph) * completion of physiotherapy programme targeting fai within past year * co-morbidities that mean surgical intervention is not possible/safe * contraindication to mri * pregnancy

Keywords: femoroacetabular impingement arthroscopy physiotherapy randomised controlled trial
prevention of cardiac dysfunction during adjuvant breast cancer therapy

Conditions: Breast Cancer; Heart Failure

Summary: women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. in this study, by using magnetic resonance imaging (mri), the investigators want to assess if heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.

breast cancer is one of the most common malignancies in women. recent progress in the detection and treatment of breast cancer has resulted in survival gains, but a consequence of therapeutic advances is an increasing number of long-term survivors who may be at risk for development of cardiovascular disease. several studies suggest that women treated for breast cancer may be at increased risk for cardiovascular disease, the probable causes being multi-factorial. importantly, therapies for breast cancer, including radiotherapy, anti-her-2 regimens and certain chemotherapeutic regimens, may increase the risk of subsequent cardiovascular disease, including atherosclerotic disease, left ventricular dysfunction, and heart failure. in the current study we propose to undertake a randomized, placebo-controlled, 2x2 factorial, double-blind trial to assess whether left ventricular dysfunction and/or injury is preventable, completely or partly, by the concomitant administration of the angiotensin receptor blocker (arb), candesartan, and the beta blocker, metoprolol, during postoperative chemotherapy and radiotherapy. the proposed study addresses an important clinical problem in a large patient group. thus, the possibility of preventing cardiovascular side effects of contemporary therapy for breast cancer is important both clinically and scientifically.

Eligibility criteria:
inclusion criteria: * women aged 18-70 years * eastern cooperative oncology group (ecog) performance status 0-1 * serum creatinine \ 60 ml/min (using the modification of diet and renal disease (mdrd) formula) * systolic blood pressure \>= 110 mghg and \< 170 mmhg * lvef \>= 50% exclusion criteria: * hypotension, defined as systolic blood pressure \< 110 mmhg * bradycardia, defined as heart rate \< 50 b.p.m. * prior anthracycline chemotherapy regimen * prior malignancy requiring chemotherapy or radiotherapy * symptomatic heart failure * systolic dysfunction (lvef \< 50%) * clinically significant coronary artery disease, valvular heart disease, significant arrhythmias, or conduction delays. * uncontrolled arterial hypertension defined as systolic blood pressure \> 170 mm hg * treatment with acei, arb or beta-blocker within the last 4 weeks prior to study start * intolerance to acei, arb or beta-blocker * uncontrolled concomitant serious illness * pregnancy or breastfeeding * active abuse of drugs or alcohol * suspected poor compliance * inability to tolerate the mri scanning protocol

Keywords: anthracyclines trastuzumab
neuromodulation in depressed and schizophrenic patients - changing mep (muscle evoked potentials) by tdcs (transcranial direct current stimulation)

Conditions: Schizophrenia; Depression

Summary: muscle evoked potentials (mep) are supposed to different in schizophrenic and depressed patients, compared to a sample of healthy volunteers. transcranial magnetic stimulation (tms)-evoked mep are measured in all three groups at baseline and after tdcs (2 ma, 20 minutes). mep amplitudes are supposed to normalize quickly in healthy volunteers, to stay diminished in depressed patients and to stay elevated in schizophrenic patients. these differences should disappear after regular pharmacological treatment. outcome measures will be done in week 2 and week 4.


Eligibility criteria:
inclusion criteria: * the patient must be in the condition to understand the patient-information, as well as the necessary examinations. * he/she must be able to give a written consent. * no medication at least three weeks before enrollment. exclusion criteria: * existence of a care/legal incapacity * existing pregnancy * severe psychiatric illness (with exception of affective disorder) * acute suicidality * drug-, medication- or alcohol dependence * dementia according to dsm iv / icd 10-criterions * severe brain infarctus in the anamnesis * indications of structural damage of the basal ganglia or the brain stem * severe neurological disorders (e.g. m. parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies). * severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like m. paget, osteoporosis with spontaneous fractures, fresh fractures) other circumstances, that speaks against a participation of the patient pinion of medical doctor at this study.

Keywords: differences of muscle evoked potentials (mep) in psychiatric illnesses differences in neuromodulation normalization of neuromodulation after pharmacological treatment
clinical performance of glass-hybrid in the treatment of class iii restorations

Conditions: Class III Dental Caries

Summary: this is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in class iii lesions. the lesions will be restored with glass hybrid restorative (equia forte) or anterior composite resin (g-aenial anterior). restorations will be evaluated after 24 months according to fdi criteria and the data will be analyzed.

the aim of this study was to comparatively evaluate the clinical performance of a glass-hybrid-restorative with an anterior composite resin (g-aenial anterior) in class iii lesions. participants who are 18 years of age or older and healthy, and who have applied to the restorative dentistry department of hacettepe university faculty of dentistry to receive treatment for class iii lesions on their front teeth will be included in the study. after explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. the gender, age, and tooth numbers of the participants to be treated will be recorded. 100 upper incisors of 50 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches. the "split-mouth" model will be used in the study, with two teeth included in one mouth and each restorative material placed in one tooth. the restorative material to be placed on the teeth will be determined randomly. before starting the restoration, papers with the names of both materials will be placed in envelopes, and then the assistant staff will be asked to randomly select one of the envelopes during the restoration stage to provide randomization.data were will be analyzed with chi- square, fisher's exact test, mann u tests

Eligibility criteria:
inclusion criteria: * the participant must be at least 18 years of age or older * the participant has at least two class iii lesions and the lesions are in symmetrical teeth located in the right and left arch * the lesion covers at most 2/3 and at least 1/3 of the dentin * participant voluntarily signing the informed consent form * the participant does not have a physical disability that may prevent them from coming to the control. * absence of a periapical pathology in the involved tooth exclusion criteria: * having systemic disorders that may prevent the participant from regularly attending treatment and control appointments. * having severe periodontal problems in the tooth planned to be treated * absence of the opposite of the tooth and not participating in chewing * lesions which is limited with the enamel tissue * teeth with lesions that are too large to be restored * patients with anterior malocclusion * patients with parafunctional habits. * mentally disabled patients.

Keywords: glass hybrid restorative class iii anterior restoration fdi criteria